Comparative Study of the Wearing Satisfaction of Two Soft Contact Lens Designs.

NCT ID: NCT00768885

Last Updated: 2013-03-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

64 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-09-30

Study Completion Date

2009-01-31

Brief Summary

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To evaluate the wearing satisfaction of a new design of the PureVision soft contact lenses.

Detailed Description

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Conditions

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Myopia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

SCREENING

Blinding Strategy

NONE

Study Groups

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PureVision 1

PureVision soft contact lens design #1.

Group Type ACTIVE_COMPARATOR

PureVision 1

Intervention Type DEVICE

Currently marketed PureVision soft contact lens.

PureVision 2

PureVision soft contact lens design #2

Group Type EXPERIMENTAL

PureVision 2

Intervention Type DEVICE

Alternate design soft contact lens.

Interventions

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PureVision 1

Currently marketed PureVision soft contact lens.

Intervention Type DEVICE

PureVision 2

Alternate design soft contact lens.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Subject is myopic
* Subjects who wear soft contact lenses that are exchanged at least biweekly at the time consent is obtained.

Exclusion Criteria

* Systemic disease affecting ocular health
* Using pharmaceuticals that may affect the function of the eyes or lenses.
* Subject possessing corneal infiltrate or corneal ulcers.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Bausch & Lomb Incorporated

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Kodama Eye Clinic

Kyoto, , Japan

Site Status

Countries

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Japan

Other Identifiers

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MDPTLD0809

Identifier Type: -

Identifier Source: org_study_id

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